FDA Label for Sleepcalm
View Indications, Usage & Precautions
Sleepcalm Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients** (in each pellet)
Chamomilla 9C HPUS (0.07 mg)
Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine)
Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids)
Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide)
Passiflora incarnata 3C HPUS (0.07 mg)
Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 mg atropine alkaloids)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Relieves Occasional Sleeplessness, Restless Sleep, Intermittent Awakening, Irritability, and Nightmares
Indications & Usage
Uses*
- temporarily relieves symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:
- restless sleep
- intermittent awakening
- irritability
- nightmares
- night terrors
- reduces time to fall asleep if your child has difficulty falling asleep
Otc - Do Not Use
Do not use if your child has a known allergy to any ingredients in this product.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Children 3 years of age or older: Dissolve 5 pellets under the tongue at bedtime, and again during the night if needed, for up to a total of 2 doses per night.
- Children under 3 years of age: Ask a doctor.
Inactive Ingredient
lactose, sucrose
Other
do not use if glued carton end flaps are open or if pellet dispenser seal is broken
contains 0.25 g of sugar per dose
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Melatonin-Free
Kids Sleep Aid*
Restores a Natural Sleep Pattern
Tubes - contains approx. 80 pellets, 3.8g (0.13 oz)
Turn tube upside down, Twist until 5 pellets are dispensed, Remove cap and pour pellets under the tongue
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Otc - Questions
BoironUSA.com
1-800-264-7661
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
